Safety and effectiveness of a glistening-free single-piece hydrophobic acrylic intraocular lens (enVista).

PURPOSE: To evaluate the safety and effectiveness of a single-piece hydrophobic acrylic intraocular lens (IOL; enVista model MX60; Bausch & Lomb, Rochester, NY, USA) when used to correct aphakia following cataract extraction in adults. METHODS: This was a prospective case series (NCT01230060) conducted in private practices in the US. Eligible subjects were adult patients with age-related cataract amenable to treatment with standard phacoemulsification/extracapsular cataract extraction. With follow-up of 6 months, primary safety and effectiveness end points included the rates of US Food and Drug Administration (FDA)-defined cumulative and persistent adverse events and the percentage of subjects who achieved best-corrected visual acuity (BCVA) of 20/40 or better at final visit. To evaluate rotational stability, subjects were randomized (1:1:1:1) to have the lens implanted in one of four axis positions in 45° increments. RESULTS: A total of 122 subjects were enrolled. The rate of cumulative and persistent adverse events did not significantly exceed historical controls, as per FDA draft guidance. At the final postoperative visit, all subjects (100%) achieved a BCVA of 20/40 compared with the FDA historical control of 96.7%. Rotation of the IOL between the two final follow-up visits was ≤5° for 100% of eyes, and refractive stability was demonstrated. A low evaluation of posterior capsule opacification score was demonstrated, and no glistenings of any grade were reported for any subject at any visit. CONCLUSION: This study demonstrated the safety and effectiveness of the MX60 IOL. Favorable clinical outcomes included preserved BCVA, excellent rotational and refractive stability, no glistenings, and a low evaluation of posterior capsule opacification score.

Comparison of through-focus image sharpness across five presbyopia-correcting intraocular lenses.

PURPOSE: To assess through-focus polychromatic image sharpness of 5 FDA-approved presbyopia-correcting intraocular lenses (IOLs) through a range of object vergences and pupil diameters using an image sharpness algorithm. DESIGN: Laboratory investigation. METHODS: A 1951 USAF resolution target was imaged through Crystalens AO (AO), Crystalens HD (HD), aspheric ReSTOR +4 (R4), aspheric ReSTOR +3 (R3), and Tecnis Multifocal Acrylic (TMF) IOL in a model eye and captured digitally for each combination of pupil diameter and object vergence. The sharpness of each digital image was objectively scored using a 2-dimensional gradient function. RESULTS: AO had the best distance image sharpness for all pupil diameters and was superior to the HD. With a 5-mm pupil, the R4 distance image sharpness was similar to the HD and at 6 mm the TMF was superior to the HD, R3, and R4. The R3 moved the near focal point farther from the patient compared to the R4, but did not improve image sharpness at intermediate distances and showed worse distance and near image sharpness. Consistent with apodization, the ReSTOR IOLs displayed better distance and poorer near image sharpness as pupil diameter increased. TMF showed consistent distance and near image sharpness across pupil diameters and the best near image sharpness for all pupil diameters. CONCLUSIONS: Differing IOL design strategies to increase depth of field are associated with quantifiable differences in image sharpness at varying vergences and pupil sizes. Objective comparison of the imaging properties of specific presbyopia-correcting IOLs in relation to patient's pupil sizes can be useful in selecting the most appropriate IOL for each patient.

Comparison of through-focus image quality across five presbyopia-correcting intraocular lenses (an American Ophthalmological Society thesis).

PURPOSE: To assess through-focus polychromatic image sharpness of five US Food and Drug Administration-approved presbyopia-correcting intraocular lenses (IOLs) through a range of object vergences and pupil diameters utilizing an image sharpness algorithm. METHODS: A 1951 US Air Force resolution target was imaged through a Crystalens AO (AO) (Bausch & Lomb Surgical, Aliso Viejo, California), Crystalens HD (HD) (Bausch & Lomb Surgical, Aliso Viejo, California), aspheric ReSTOR +4.0 (R4) (Alcon Laboratories, Fort Worth, Texas), aspheric ReSTOR +3.0 (R3) (Alcon Laboratories, Fort Worth, Texas), and Tecnis Multifocal Acrylic (TMF) (Abbott Medical Optics, Irvine, California) IOL in an anatomically and optically accurate model eye and captured digitally for each combination of pupil diameter and object vergence. The sharpness of each digital image was objectively scored using a two-dimensional gradient function. RESULTS: The AO lens had the best distance image sharpness for all pupil diameters, followed by the HD. With a 5-mm pupil, the R4 lens achieved distance image quality similar to the HD, but inferior to the AO. The R3 successfully moved the near focal point farther from the patient compared to the R4, but did not improve image sharpness at intermediate distances and showed worse distance and near image sharpness. Consistent with apodization, the ReSTOR IOLs displayed better distance and poorer near image sharpness as pupil diameter increased. The TMF lens showed consistent distance and near image sharpness across pupil diameters and exhibited the best near image sharpness for all pupil diameters. CONCLUSIONS: Differing IOL design strategies to increase depth of field are associated with quantifiable differences in image sharpness at varying vergences and pupil sizes. An objective comparison of the imaging properties of specific presbyopia-correcting IOLs, in conjunction with patients' pupil sizes, can be useful in selecting the most appropriate IOL for each patient.

Optical performance of 3 intraocular lens designs in the presence of decentration.

PURPOSE: To study the theoretical optical performance of 3 intraocular lens (IOL) designs in the presence of IOL decentration. SETTING: Optics Center, Bausch & Lomb, Rochester, New York, USA. METHODS: A ray-tracing program was used to evaluate the effect of IOL decentration on the optical performance of 3 silicone IOLs (LI61U, Bausch & Lomb; Tecnis Z9000, Advanced Medical Optics; and a new aberration-free IOL [SofPort AO, Bausch & Lomb]) in an experimental model eye. The study was done using pupil diameters of 3.0 mm, 4.0 mm, and 5.0 mm and IOL decentrations of 0 mm, 0.25 mm, 0.50 mm, 0.75 mm, and 1.00 mm. The modulation transfer functions were computed and plotted. A Monte Carlo simulation analysis with 1000 trials with IOL decentration randomly varying for each pupil size was performed. RESULTS: Decentration of LI61U and Tecnis Z9000 IOLs led to asymmetrical higher-order aberrations that adversely affected the optical performance of the model eye; performance was not affected with the aberration-free IOL because it lacks inherent spherical aberration. Optical performance with the aberration-free IOL was better than with the LI61U IOL as the former has less spherical aberration and did not introduce other aberrations when decentered. Performance with the aberration-free IOL was better than with the Tecnis Z9000 IOL for 3.0 mm, 4.0 mm, and 5.0 mm pupils when decentration exceeded 0.15 mm, 0.30 mm, and 0.38 mm, respectively. Performance with the LI61U IOL was better than with the Tecnis Z9000 IOL for 3.0 mm, 4.0 mm, and 5.0 mm pupils when decentration exceeded 0.3 mm, 0.5 mm, and 0.5 mm, respectively. Monte Carlo simulations showed the expected postoperative results of the LI61U IOL and aberration-free IOL would be repeatable and predictable, whereas the outcomes with the Tecnis Z9000 IOL would vary widely. CONCLUSIONS: The optical performance of the model eye was not affected by decentration of an aspheric IOL designed to have no inherent spherical aberration. With decentration, the performance with the new IOL was better than with a conventional spherical IOL and an aspheric IOL designed to offset the spherical aberration of an average cornea.

Wavefront-customized intraocular lenses.

PURPOSE OF REVIEW: Recent advances in ocular wavefront measurement and in intraocular lens materials and manufacturing methods have brought cataract surgery to the brink of a period in which customized correction of higher-order aberrations with intraocular lenses may become standard practice. RECENT FINDINGS: Retinal image quality in pseudophakic eyes is limited by the wavefront aberrations of the cornea and the intraocular lens. The Tecnis Z9000 is the first commercially available intraocular lens designed to account for the wavefront aberrations of the cornea, specifically spherical aberration. Clinical findings with the Tecnis Z9000 intraocular lens show improved contrast sensitivity at low and mid spatial frequencies. However, if the lens decenters or tilts modestly, higher-order aberrations are created, and the lens may underperform relative to standard intraocular lenses. At present, one firm is developing an intraocular lens that may be modified in vivo with near ultraviolet energy. Such a technology offers tremendous potential for a fully customized intraocular lens. SUMMARY: Wavefront-customized intraocular lenses offer the promise of near perfect retinal image quality, such that only diffraction, chromatic aberration, retinal sampling and neural factors will limit vision in pseudophakic eyes.